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CIRCULAR No

CIRCULAR No. 10/2001/TT-BYT OF MAY 22, 2001 GUIDING FOREIGN INVESTMENT IN THE FIELD OF MEDICAL EXAMINATION AND TREATMENT IN VIETNAM

Pursuant to the Law on Protection of People’s Health and legal documents guiding the implementation thereof;

Pursuant to the November 12, 1996 Law on Foreign Investment in Vietnam, the June 9, 2000 Law Amending and Supplementing a Number of Articles of the Law on Foreign Investment in Vietnam and the legal documents guiding the implementation of the Law on Foreign Investment in Vietnam; the Government’s Decree No.06/2000/ND-CP of March 6, 2000 on investment cooperation with foreign countries in the field of medical examination and treatment, education and training and scientific research;

Pursuant to the Law on Enterprises and legal documents guiding the implementation thereof; the Government’s Decree No.11/1999/ND-CP of March 3, 1999 on goods banned from circulation; commercial services banned from provision; goods and commercial services subject to business restriction or conditional business;

Pursuant to the Ordinance on Private Practice of Medicine and Pharmacy, Decree No.06/CP of January 29, 1994 detailing a number of articles of the Ordinance on Private Practice of Medicine and Pharmacy as well as legal documents guiding the implementation of the above Ordinance and Decree;

Pursuant to Circular No.08/2000/TT-BLDTBXH of March 29, 2000 of the Ministry of Labor, War Invalids and Social Affairs guiding the granting of work permits for foreigners working at enterprises or organizations in Vietnam;

After obtaining opinions of the Ministry of Planning and Investment in Official Dispatch No.2096/BKH-PLDT of April 9, 2001, the Health Ministry hereby guides the foreign investment in the field of medical examination and treatment in Vietnam as follows:

Chapter I

GENERAL PROVISIONS

Article 1.- Foreign organizations and individuals may invest in the field of medical examination and treatment in Vietnam in the following forms of medical examination and treatment and investment forms:

1. Forms of medical examination and treatment:

1.1. Hospital:

a/ General hospital.

b/ Specialized hospital.

1.2. Consultation clinics pre-clinical establishments:

a/ General consultation clinic is the one with various (at least 2) specialties.

b/ Specialized consultation clinic.

c/ Maternity home.

d/ Pre-clinical specialized consultation clinic.

1.3. Services in support of patient transportation abroad.

Foreign-invested medical examination and/or treatment establishments or other establishments which are fully qualified under the provisions in Clause 14, Article 9 of this Circular may register their services in support of patient transportation abroad.

2. Forms of investment:

a/ Joint venture.

b/ 100% foreign capital.

c/ Business cooperation on the basis of business cooperation contracts.

Article 2.- Vietnamese organizations entitled to undertake investment cooperation with foreign countries in setting up medical examination and/or treatment establishments with foreign capital shall include:

1. Hospitals, general or specialized clinics, medical examination and/or treatment establishments being Vietnamese public-service units with revenue.

2. Semi-public hospitals, general or specialized clinics and maternity homes.

3. Private hospitals, general or specialized clinics and maternity homes.

4. Subjects specified in Article 2 of Decree No.24/2000/ND-CP of July 31, 2000 of the Government detailing the implementation of the Law on Foreign Investment in Vietnam.

Article 3.- Foreign-invested medical examination and/or treatment establishments set up in forms specified at Points 1.1 and 1.2 of Clause 1, Article 1 of this Circular must satisfy all conditions prescribed by the legislation on foreign investment in Vietnam, the legislation on private practice of medicine and pharmacy and other relevant law provisions and observe the professional and technical regulations promulgated by the Health Ministry.

Article 4.-

1. The Ministry of Planning and Investment shall consider and grant investment licenses to foreign-invested medical examination and/or treatment establishments after getting the written agreement of the Health Ministry on the basis of considering the initial investment projects in compatibility with the planning on organization of medical examination and treatment networks, subjects to be provided with services in localities where the foreign-invested medical examination and/or treatment establishments are located.

2. After the foreign-invested medical examination and/or treatment establishments are constructed and fully furnished with equipment, infrastructure, organizational apparatus and personnel, the Health Ministry shall make appraisal and grant the certificates of full qualification for practice of medical examination and/or treatment.

3. Only after getting the certificates of full qualification for practice of medical examination and/or treatment, granted by the Health Ministry, can the foreign-invested medical examination and/or treatment establishments commence their operation.

Article 5.- The foreign-invested medical examination and/or treatment establishments must strictly adhere to the scope of professional operations permitted by the Health Ministry. The medical examination and treatment charges must be appropriate, based on the quality of equipment, infrastructure, professional qualifications of physicians and medical staffs.

Article 6.-

1. Foreign-invested medical examination and/or treatment establishments shall have to carry out procedures to re-apply for certificates of full qualification for practice of medical examination and/or treatment in the following cases:

- Forms of investment or forms of medical examination and/or treatment change.

- Medical examination and/or treatment establishments are split up or merged.

- Places for medical examination and/or treatment practice are relocated.

- Certificates expire.

2. While the certificates of full qualification for medical examination and/or treatment practice remain valid but their investors or directors are replaced, the medical examination and/or treatment establishments shall have to report such to the Health Minister. The new directors of the medical examination and/or treatment establishments must acquire certificates of medical examination and/or treatment practice.

Article 7.- Foreign- invested medical examination and/or treatment establishments shall have to pay charges, fees for the appraisal of the professional practice conditions as provided for by law.

Chapter II

CONDITIONS AND SCOPES OF PROFESSIONAL ACTIVITIES OF FOREIGN-INVESTED MEDICAL EXAMINATION AND/OR TREATMENT ESTABLISHMENTS

Article 8.- General conditions:

1. Foreign-invested medical examination and/or treatment establishments must apply modern methods to the provision of diagnosis, treatment and care for patients with high quality, ensuring the efficiency and safety for patients.

2. Foreign-invested medical examination and/or treatment establishments must be furnished with modern medical equipment suitable to each form of medical examination and/or treatment, which are being used in the world. Their infrastructures and medical staffs must be compatible to the modern medical equipment and the approved professional as well as technical scopes; they must be furnished with first-aid medicine cabinets and anti-shock drug boxes (according to Appendix 1), power and water supply systems, toilets, fire fighting devices…, ensure environmental sanitation, treat waste strictly according to the provisions of law.

3. Directors (used to collectively refer to the directors of hospitals, the heads of general consultation clinic, the heads of specialized consultation clinics, the heads of laboratories, the heads of maternity homes) of foreign-invested hospitals or medical examination and treatment establishments must acquire the medical examination and/or treatment practice certificates granted by the Health Ministry. Physicians and medical staffs working at foreign-invested medical examination and/or treatment establishments must have professional diplomas, certificates suitable to their assigned jobs and have practiced their specialties for more than 3 years.

4. Foreign-invested medical examination and/or treatment establishments must draw up plans for cooperation on technology transfer and training of Vietnamese personnel.

Article 9.- Specific conditions: Apart from the general conditions prescribed in Article 8 of this Circular, the foreign-invested medical examination and/or treatment establishments must satisfy the following specific conditions:

1. Hospitals: Hospital are medical examination and treatment establishments which provide treatment to in-patients and out-patients. They may be general hospitals or specialized hospitals.

1.1. Conditions for a hospital to be licensed for medical examination and treatment activities:

a/ The hospital director is a physician who has the medical examination and treatment practice and hospital registration certificates granted by the Health Ministry.

The department heads in the hospital are specialized physicians who have practiced their profession for 5 years at lawful medical examination and treatment establishments, including 3 years for practice of their specialties.

b/ The hospital has at least 21 beds.

c/ The organization and personnel is compatible with the hospital size.

d/ The hospital must fully have:

+ The consultation department.

+ The emergency department.

+ The therapy departments.

+ The pre-clinical departments.

1.2. Scope of professional operation: To comply with the list of domains of professional operation already approved by the Health Ministry. The hospitals must admit patients in the state of emergency and may transfer them to their registered hospital only after providing emergency treatment.

2. General consultation clinics: A general consultation clinic is a medical examination and treatment establishment consisting of many (at least 2) specialized consultation rooms and headed by a director.

2.1. Conditions for a general consultation clinic to be licensed for medical examination and treatment activities:

a/ The clinic director is a physician who has the medical examination and treatment practice and general consultation clinic registration, certificates granted by the Health Ministry.

The heads of the specialized consultation rooms in the general consultation clinic are specialized physicians who have practiced their profession at lawful medical examination and treatment establishments for 5 years, including 3 years for specialty practice.

b/ Infrastructure: The specialized consultation rooms in the general consultation clinic must be large enough and adequately furnished with equipment and facilities like the specialized consultation rooms as provided for in this Circular. Apart from the above provisions, the general consultation clinic must necessarily have a waiting room, an emergency room, a confinement room (with no more than 10 beds and the confinement shall not last more than 24 hours).

2.2. Scope of professional operation: To practice profession according to the approved lists of specialties.

3. Internal medicine consultation clinics: The internal medicine consultation clinics include the following types:

- The general internal consultation room.

- The specialized internal medicine consultation rooms.

- The family consultation room.

- The via-telephone health consultancy room.

3.1. Conditions for an internal medicine consultation clinic to be licensed for medical examination and treatment activities:

a/ The clinic head is a physician who has the medical examination and treatment practice and internal medicine consultation clinic registration certificates granted by the Health Ministry.

b) Its general internal medicine consultation room, specialized internal medicine consultation rooms and family consultation room must be furnished with professional equipment and facilities suitable to the scope of professional operations.

It must have a separate examination room of at least 10m2, examination beds and working desks.

Particularly the via-telephone health consultancy room shall not have to comply with the provisions at Point b, Clause 3.1 of this Article.

3.2. Scope of professional operations:

a/ For the general internal medicine consultation room and the family consultation room:

- Advising on health and family planning.

- Managing health.

- Providing first-aid, primary emergency care, examination and prescription, treatment of common diseases, not performing specialized operations. Detecting cases which go beyond its capacity and transferring them to specialized consultation rooms or higher-level establishment.

- Providing surgery consultation: Providing bone fracture first- aid without casting, without operations.

- Providing obstetric examination: Pregnancy check, birth management, not performing child delivery.

- Providing dental check, non-extraction of teeth.

- Providing ear-nose-throat (otorhinolaryngological) examination, without slitting middle-ear inflation.

- Collecting samples for test, without vivisection or puncture.

- Providing electro-cardiography, ultrasonography…; no need to grant of separate certificate, but there must be certificate of professional fostering and practice of this specialty, granted by a lawful medical examination and treatment establishment, being granted a certificate of permission to include this in the scope of professional practice by a competent body.

b/ Specialized internal medicine consultation rooms: checking, diagnosing and treating diseases falling under the approved specialties.

4. Specialized surgery consultation clinic:

4.1. Conditions for a specialized surgery consultation clinic to be licensed for medical examination and treatment activities:

a/ The clinic head is a physician who has the medical examination and treatment practice and surgery consultation clinic registration certificates granted by the Health Ministry.

b/ The specialized surgery consultation clinic must be equipped with devices and rooms for minor operations, emergency room and patient confinement room, and must pay special attention to the anti-infection techniques.

4.2. Scope of professional operations:

- Providing surgery first-aid, primary emergency care.

- Examining and treating common wounds.

- Casting small bone fractures.

- De-casting under direction of the physicians who provided castings for patients.

- Threading small hemorrhoids, operating on cystic tumors, colliculus.

- Not pricking big diffuse puses.

5. Specialized obstetric consultation- family planning clinic:

5.1. Conditions for a specialized obstetric consultation- family planning clinic to be licensed for medical examination and treatment activities:

a/ The clinic head is a physician having the medical examination and treatment practice and specialized obstetric consultation-family planning clinic registration certificates granted by the Health Ministry.

b/ It has separate examination room of at least 10m2, examination couches, tools and performing minor obstetric operations. Besides the examination rooms, there are operation rooms.

5.2. Scope of professional operations:

- Advising on health education and family planning.

- Providing obstetric first-aid.

- Giving pregnancy check, management.

- Examining and treating common gynecological diseases.

- Placing vagina medicaments.

- Uterocervical cautery for treatment.

- Uterocerviscopy, collecting samples for K tissues.

- Placing IUD.

- Under 15 days-fetus suction.

- Non-knife male sterilization.

- Not performing abortion, IUD removal and female sterilization.

- Not performing child delivery at clinic.

6. The specialized dental-jaw-facial consultation clinic:

6.1. Conditions for a specialized dental-jaw-facial consultation clinic to be licensed for medical examination and treatment activities:

a/ The clinic head is a physician having the medical examination and treatment practice and dental-jaw-facial consultation clinic registration certificates granted by the Health Ministry.

b/ It adequately has rooms for minor operations, working rooms suitable to the scope of professional practice.

6.2. Scope of professional operations:

- Examining and treating common diseases, providing first aid to jaw and facial injuries.

- Performing minor operations to remove scars of facial injuries of under 2 cm.

- Resetting jaw joints.

- Providing laser surface treatment.

- Treating fangitis.

- Pricking abscesses, removing tartar, extracting teeth.

- Making false teeth, dental plates.

7. Specialized otorhinolaryngological consultation clinic:

7.1.Conditions for a specialized otorhinolaryn-gological consultation clinic to be licensed for medical examination and treatment activities : The clinic head is a physician having the medical examination and treatment practice and specalized otorhinolaryngological consultation clinic registration, certificates granted by the Health Ministry.

7.2. Scope of professional operations:

- Providing otorhinolaryngological first aid.

- Examining, treating common diseases:

+ Sinusitis, probing cavity, probing and sucking ulcer mucus.

+ Pricking urgent middle ear infection.

+ Pricking tonsil abscess.

+ Cutting polyps, otorhinolaryngological cysts, adipose tumors.

+ Nose bleed stoppage.

+ Removing stranger objects from ears, noses and throats. Not removing stranger objects from larynx or gullet.

+ Thermo- or laser laryn cautery.

+ Sewing up head and neck wounds of under 5cm.

+ Adenoidectomy.

8. Specialized opthalmological consultation clinic:

8.1. Conditions for a specialized opthalmological clinic to be licensed for medical examination and treatment operations: The clinic head is a physician having the practicing medical examination and treatment allowed for specialized opthalmological clinic registration certificates granted by the Health Ministry.

8.2. Scope of professional operations:

- Providing opthalmological first-aid, treating common eye diseases.

- Giving under-conjunctiva, close-eyeball and behind-eyeball injections.

- Removing strange objects from conjunctiva, pricking styes; operating on entropion, iritis.

- Cleaning out lacrimal glands.

9. Specialized plastic surgery clinics are establishments which provide plastic surgery services and are headed by physicians.

9.1. Conditions for a specialized plastic surgery clinic to be licensed for operation:

a/ The clinic head is a physician having the medical examination and treatment practice and specialized plastic surgery clinic registration certificates granted by the Health Ministry.

b/ The establishment must be sterile and have adequate rooms for surgery, patient confinement, waiting.

c/ If minor operations change the personal identification, they must be consented by the police office.

9.2. Scope of professional operations:

- Lip and eyelid pricking.

- Pustule pus extraction; tending services that cause bleeding.

- Hair transplant;

- Raising sunken cheekbones, nose bridges.

- Face skin plastic surgery.

- Treating wrinkles on upper or lower eyelids, one-lid, double-lid eye plasty.

10. Specialized convalescence- functional rehabilitation and physiotherapy clinic:

10.1. Conditions for a specialized convalescence- functional rehabilitation and physio-therapy clinic to be licensed for medical examination and treatment activities: The clinic head is a physician having the medical examination and treatment practice and specialized convalescene-functional rehabilitation and physiotherapy registration certificates granted by the Health Ministry.

10.2. Scope of professional operations:

- Taking care of syndromes of centroneural and ectoneural paralysis.

- Taking care of chronic rheumeteological diseases.

- Providing post-surgery care for further functional rehabilitation.

- Applying the following techniques:

+ Massage, digital punction, acupuncture.

+ Approved physio-therapeutic methods.

+ Therapeutic operations.

11. Image diagnosis clinics: are establishments which contribute to medical diagnosis and monitoring of the results of therapy by X-ray equipment, ultrasonic equipment.

11.1. Conditions for an image diagnosis clinic to be licensed for medical examination and treatment activities:

a/ The clinic head is a physician having the medical examination and treatment practice and specialized image diagnosis clinic registration certificates granted by the Health Ministry.

b/ It is adequately furnished with personal protection devices, X-ray room up to the radiation safety standard and granted the radiation safety permit. Its infrastructure must ensure absolute safety. It must have the waiting room, the X-ray room, the film developing and printing room, the film reading room….The room where equipment are installed must be at least 3.5m high, have its walls plastered with barite, its door shielded with lead sheet and its floor being high and airy.

11.2. Scope of professional operations:

- X-ray diagnosis, CT scanner, magnetic resonance.

- Ultrasonic doppler diagnosis, common ultrasonic diagnosis, echo-endoscopy.

- Non-use of vein photo-reflection.

- Not performing echo-guided probes, endoscopy surgery, bronchiscopy, nor bleeding intervention by X-ray.

12. Laboratory: Laboratory is an establishment which helps the diagnosis and monitors therapy, including hematological, bio-chemical, micro-biological testing, microsome operations.

12.1. Conditions for a laboratory to be licensed for operations:

a/ The lab head is a physician or a pharmacist, bachelor of biology or chemistry, having the medical examination and treatment practice and specialized lab consultation registration certificates granted by the Health Ministry.

b/ Its infrastructure must be up to the lab standards; its architectural and organizational designs must ensure labor safety strictly according to the regulations on scientific laboratory work. Apart from the testing area, attention should be paid to support section such as power and water supply as well as fire prevention and fighting.

12.2. Scope of professional operation: Making hematological, bio-chemical, micro-biological, parasitical tests, microsome operations.

13. Maternity homes are establishments where children are delivered, gestation and childbirth are managed.

13.1. Conditions for a maternity home to be licensed for operation:

a/ Its head is a physician having the practicing medical examination and treatment practice and maternity home registration certificates granted by the Health Ministry. He/she must work as a full-time practitioner.

b/ Infrastructure: It must have the childbirth waiting room, delivery room, post-natal room, which must be sterile and airy.

13.2. Scope of professional operation:

- Giving pregnancy examinations, managing gestation and childbirth.

- Providing obstetric first-aid and primary emergency care.

- Giving anti-tetanus injection as provided for expecting mothers.

- Giving urethral protein test.

- Providing ordinary childbirth.

- Cutting, sewing up hormone-producing layers upon direction, pitching up hormone-producing layers of grade I.

- Under-12 week-fetus suction, abortion.

- Post-natal, post-miscarriage placental leftover scraping.

- Performing difficult child delivery, sucker.

- Placing IUD, not removing IUD, not allowed to perform obstetric operations of type 1.

14. Service establishments in support of transporting patients abroad: Conditions for a service establishment in support of transporting patients abroad to be licensed for operations:

- It must be a foreign-invested medical examination and treatment establishment. Its director must have the medical examination and treatment practice certificate.

- It must have enough physicians, emergency and recuperation personnel, transport means, medical equipment and instruments as well as first-aid medicine to ensure safety for patients while being transported.

- It signs contracts with the airline service company for the transportation of patients.

Chapter III

DOSSIERS, PROCEDURES AND COMPETENCE FOR GRANTING OF MEDICAL EXAMINATION AND TREATMENT PRACTICE CERTIFICATES

Article 10.- Dossiers and procedures

1. For individuals registering foreign-invested medical examination and treatment establishments, who are foreigners or overseas Vietnamese:

a/ Dossiers:

- The application for medical examination and treatment practice certificate.

- The written commitment to observe the Vietnamese law provisions on public health as well as other relevant law provisions.

- The copies of professional diplomas, certificates, professional practice certificate or written certification of the practice duration of more than 5 years in the host countries (certified by State Notary Public).

- The work permits granted by provincial/municipal Services of Labor, War Invalids and Social Affairs to foreign laborers working in the provinces or centrally-run cities under their management.

b/ Procedures: The dossiers applying for medical examination and treatment practice certificates shall be sent to the Health Ministry (the Therapy Department). Within 30 days after receiving the complete and valid dossiers, the Health Ministry shall grant the medical examination and treatment practice certificate; in case of refusal, the applicants must be notified thereof in writing.

2. For individuals registering foreign-invested medical examination and treatment establishments, who bear Vietnamese nationality:

a/ Dossiers: To comply with the Health Minister’s Circular No.19/2000/TT-BYT of November 24, 2000 guiding the consideration and granting of medical examination and treatment practice certificates.

b/ Procedures: 15 days after the Health Ministry receives the valid dossiers, the applicants shall be informed of the time to sit for tests before being granted the medical examination and treatment practice certificates. The Health Ministry shall organize tests for the granting of medical examination and treatment practice certificates in the third month of every quarter.

Article 11.- Competence to grant medical examination and treatment practice certificates:

The Health Minister shall consider and grant medical examination and treatment certificates to persons who fully meet the criteria as provided for in this Circular for registering foreign-invested medical examination and treatment establishments. The medical examination and treatment practice certificates shall be valid nationwide for 5 years counting from the date of issuance. After such 5-year time limit, the medical examination and treatment practice certificate holders must submit to the Health Ministry the written certification of their participation in training courses on professional knowledge updating in order to fill in the procedures for extension of their medical examination and treatment practice certificates.

Chapter IV

DOSSIERS, PROCEDURES AND COMPETENCE FOR GRANTING CERTIFICATES OF FULL QUALIFICATION FOR MEDICAL EXAMINATION AND TREATMENT PRACTICE

Article 12.- The dossiers of application for the "certificate of full qualification for medical examination and treatment practice".

Article 13.- The appraising procedures for the granting of "certificate of full qualification for medical examination and treatment practice":

1. The establishments applying for certificates of full qualification for medical examination and treatment practice must send their dossiers to the Health Ministry (The Therapy Department).

2. The contents of the appraisal record:

All documents shall be sent in their originals enclosed with the Vietnamese translations thereof; the Vietnamese translations and their copies must all be notarized by the State Notary Public.

Article 14.- Competence to grant certificates of full qualification for medical examination and treatment practice.

1. The Health Minister shall grant "certificates of full qualification for medical examination and treatment practice" to foreign-invested medical examination and treatment establishments.

2. The Health Ministry shall set up the Appraisal Council to assist the Minister in considering the qualifications for being granted the certificates. The Council shall be composed of a vice-minister as its president; the Therapy Department director as its standing vice-president, a representative of Vietnam Medicine and Pharmacy Confederation and other members. Any appraisal shall be participated also by a representative of the provincial/ municipal Health Service and a representative of the foreign-invested medical examination and treatment establishment.

Article 15.- Effective duration of certificates of full qualification for medical examination and treatment practice:

1. The certificates of full qualification for medical examination and treatment practice, granted by the Health Minister shall be valid for 5 years as from the date of issuance.

2. Three months before their expiry, establishments shall have to fill in procedures to apply for their extension.

2.1. Dossiers:

+ The application for extension.

+ The already granted certificate of full qualification for medical examination and treatment practice.

+ The report on operation of the foreign-invested medical examination and treatment establishment in 5 years: The report should clearly state the concrete situation on medical examination and treatment activities in 5 years, the status of infrastructure and medical equipment, technical progress, achievements and existing problems as well as remedial measures, development orientation in the time to come….

+ The health check papers of the establishment director, department heads, physicians, medical personnel and other employees.

2.2. Procedures: The dossiers shall be addressed to the Health Ministry ( the Therapy Department); the Health Ministry shall set up the appraisal team to consider the extension of the certificate of full qualification for medical examination and treatment practice.

3. The certificates of full qualification for medical examination and treatment practice shall be sent and kept as follows: The certificate granted by the Health Minister shall be made in 4 copies: 1 copy shall be sent to the provincial/municipal Health Service, 1 copy to the involved party, and 2 copies kept at the Health Ministry.

Chapter V

RIGHTS AND OBLIGATIONS OF FOREIGN-INVESTED MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 16.- Apart from the rights and obligations prescribed in Chapter III of the Ordinance on Private Practice of Medicine and Pharmacy and Article 16 of the Government’s Decree No.06/CP of January 29, 1994 detailing a number of articles of the Ordinance on Private Practice of Medicine and Pharmacy, Chapter V (Investment encouragement and preferences) of the Government’s Decree No.06/2000/ND-CP of March 6, 2000 on cooperation with foreign countries on investment in the fields of medical examination and treatment, education and training, scientific research. The foreign-invested medical examination and treatment establishments shall have the following rights and obligations:

1. Rights:

- The foreign-invested hospitals may organize drug stores to supply medicines for outpatients strictly according to the law-prescribed procedures. If no drug stores are set up, the hospitals must have the pharmacy departments to supply medicines for inpatients.

- Doctors, pharmacists and medical personnel working in foreign-invested medical examination and treatment establishments may follow long-term study courses according to the State’s enrolment regulations to raise their professional levels; regularly participate in professional activities and fostering of the branch, attend refresher courses on knowledge updating, particularly those on dangerous diseases (malaria, cholera, typhoid, HIV/AIDS…). The Health Services of the provinces and centrally-run cities (referred collectively to as the provinces) shall have to coordinate with the provincial Society of Medicine and Pharmacy in organizing professional training, fostering, knowledge updating for the above-said subjects.

- Medical examination and treatment establishments and individuals having merits in servicing patients shall be commended and/or rewarded according to the common regime of the State of the Socialist Republic of Vietnam.

- The directors of the foreign-invested medical examination and treatment establishments must take responsibility before Vietnamese law for the entire medical examination and treatment activities of their establishments.

- The foreign-invested medical examination and treatment establishments are entitled to enjoy investment encouragement and preferences prescribed in Articles 18,19,20,21,22 and 23 of the Government’s Decree No.06/2000/ND-CP of March 6, 2000.

2. Obligations:

- To fulfill all tax and financial obligations like foreign-invested enterprises and enjoy investment encouragement and preferences according to the legislation on foreign investment in Vietnam.

- The foreign-invested medical examination and treatment establishments are encouraged to deduct their annual profits to organize free-of- charge medical examination and treatment or to render support for the poor, disaster victims.

- To put up signboards as prescribed, to publicly post up the hospital fees, detailed scope of professional practice; to strictly adhere to permitted practicing scopes and approved hospital fees. The foreign-invested medical examination and treatment establishments must draw up hospital fee tables and report them to the Health Ministry for approval.

- Not to prescribe, use type of medicines, use medical equipment, which have not yet permitted for circulation, not to apply new techniques not yet permitted by the Health Ministry.

- To be obliged to participate in the prevention of and combat against epidemics, in national health programs. Not allowed to sell for profits(State-subsidized and free-of-charge) drugs and instruments under programs.

- To sign contracts with medical examination and treatment establishments of the Vietnamese State for technical support and transfer of patients when so requested.

- To abide by the stipulations in the "Hospital Regulations" promulgated together with the Health Minister’s Decision No.1895/1997/BYT-QD of September 19, 1997 (the case history must be written in Vietnamese language or bilingually in Vietnamese and a foreign language selected by the medical examination and treatment establishments themselves), to observe the regime of particular professional allowances like the State-run medical examination and treatment establishments and other relevant law provisions.

Chapter VI

THE STATE’S PROFESSIONAL AND TECHNICAL MANAGEMENT OVER FOREIGN-INVESTED MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 17.-

- The Health Ministry performs the function of State management professional and technical over the foreign-invested medical examination and treatment establishments throughout the country.

- The provincial Health Services exercises the State’s professional and technical management over the foreign-invested medical examination and treatment establishments in the geographical areas under their respective management.

Article 18.- The foreign-invested medical examination and treatment establishments shall have to observe the regime of quarterly, biannual and annual reporting to the provincial Health Services and the Health Ministry according to the Hospital Regulations, promulgated together with the Health Minister’s Decision No.1895/1997-BYT-QD of September 9, 1997.

- The periodical reports sent by the provincial Health Services to the Health Ministry must contain section on management of foreign-invested medical examination and treatment establishments in the localities.

- Annually, the provincial Health Services draw up separate reports on foreign-invested medical examination and treatment.

Chapter VII

EXAMINATION, INSPECTION AND HANDLING OF VIOLATIONS

Article 19.- The Health Ministry shall organize regular or irregular examinations and inspections of the observance of law provisions on practice of medical examination and treatment in foreign-invested establishments throughout the country.

The provincial Health Services shall organize regular or irregular examinations and inspections of the observance of law provisions on practice of medical examination and treatment in foreign-invested establishments in their respective localities.

The foreign-invested medical examination and treatment establishments must abide by and create favorable conditions for the examinations and inspections at their places.

Article 20.- The foreign-invested medical examination and treatment establishments and individuals practicing their profession therein, if violating the provisions of this Circular, the provisions on medical profession and techniques as well as other relevant law provisions, shall be handled according to law provisions.

Chapter VIII

IMPLEMENTATION PROVISIONS

Article 21.- This Circular takes effect 15 days after its signing for promulgation and replaces Circular No.22/BYT-TT of December 29, 1994 of the Health Minister guiding foreign investment in the field of medical examination and treatment in Vietnam.

Article 22.- Those foreign-invested medical examination and treatment establishments which have been granted the "certificates of criteria and qualification for setting up foreign-invested medical examination and treatment establishment according to the provisions of Circular No.22/BYT-TT of December 29, 1994 of the Health Minister shall, 5 months before their expiry, have to carry out procedures to apply for the granting of new certificates under the provisions of this Circular.

Minister of Health
DO NGUYEN PHUONG

APPENDIX 1

LIST OF EMERGENCY DRUGS APPLICABLE TO FOREIGN-INVESTED MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

(Promulgated together with Circular No. 10/2001/TT-BYT of May 22, 2001)

Ordinal number

Drug names

Passage, dose, preparation forms

Quantity

1

Acetylsalicylic acid

Oral, tablet or powder pack of 100-300-500 mg

10 tablets

2

Aminophylline

Injection, ampoule 25mg/ml, ampoule of 10ml,

Oral, tablet of 300mg

5 ampoules

10 tablets

3

Ampicillin (sodium salt)

Injection, vial of 500-1,000 mg

5 vials

4

Atropin sulfate

Injection, ampoule of 0.25 mg/1ml

05 ampoules

5

Artesunat

Oral, tablet of 50 mg

Injection, vial of 60 mg powder + 0.6ml of 5% sodium carbonate solution

10 tablets

05 vials

6

Benzylpenicillin (potassium or sodium salt)

Injection, vial of 200,000 UI - 1,000,000 UI

05 vials

7

Calcium chloride

Injection, ampoule of 500mg/5ml

05 ampoules

8

Chloropromazin

Injection, ampoule of 25mg/2ml

05 ampoules

9

Co-trimoxazol

Oral, tablet of 480 mg

10 tablets

11

Diphenhydramine

Injection, ampoule of 10-30-50 mg

05 ampoules

12

Gentamicin

Injection, ampoule of 40mg - 80mg

05 ampoules

13

Glucose

Injection, 30% solution, ampoule of 10ml

05 ampoules

14

Glyceryl trinitrate

Oral, tablet of 0.5mg - 2.5mg

10 tablets

15

Furosemid

Injection, ampoule of 20mg/2ml

05 ampoules

16

Heptaminol (Hydrochloride)

Oral, tablet of 150mg

10 tablets

17

Isoprenallin

Injection, ampoule of 2mg/1ml

05 ampoules

18

Lidocain (Hydrochloride)

Injection, ampoule of 1-2-5ml, solution of 1%-2%

05 ampoules

19

Loperamide (HCL)

Oral, tablet of 2mg

10 tablets

20

Metronidazol

Injection, bottle of 500mg/100ml

01 bottle

21

Sodium hydrocarbonate

Injection, ampoule of 10ml, solution of 1.4%

10 ampoules

22

Sodium thiosulfate

Tablet of 330mg

Injection, 100mg/ml and 200mg/ml,ampoule of 10ml

10 tablets

05 ampoules

23

Nifedipin

Oral, tablet of 10mg-20mg

10 tablets

24

Oresol (ORS)

Oral, powder pack of 27.9g/l mixed with 1 liter of cool boiled water

05 packs

25

Panthenol

Spray, box

01 vial

26

Papaverin (Hydrochloride)

Oral, tablet of 40mg

20 tablets

27

Paracetamol

Oral, tablet of 100-500mg

Placing, pellet of 100mg

10 tablets

05 pellets

28

Paracetamol + Detextropropoxyphene chlohydrate

Oral, Paracetamol tablets of 400 mg + Detextropropoxyphene chlohydrate, pill of 30mg

10 tablets

29

Propacetamol (Chlohydrate)

Intramuscular, vein injection, ampoule of 1g propacetamol chlohydrate + ampoule of citrate trisodique solvent

05 ampoules

30

Promethazine

Oral, sugar-coated pill of 10mg-50mg

10 pills

31

Propranolol (Hydrochloride)

Oral, pill of 40mg

10 pills

32

Quinin (Hydrochloride)

Injection, ampoule of 500mg/ml

05 ampoules

33

Salbutamol (Sulfate)

Oral, tablet of 2-4mg

Spray, box of 0.1mg/dose

10 tablets

01 box

34

Activated carbon

Powder pack of 20mg, oral

10 packs

35

Naloxone

Injection, ampoule of 0.5mg

05 ampoules

36

PAM

Oral, tablet of 1g

20 tablets

37

Sorbitol

Powder pack of 5g, oral

10 packs

35

Vitamin K1

Injection, ampoule of 5mg/1ml

05 ampoules

38

Vitamin B1

Injection, ampoule of 25mg

05 ampoules

ADDICTIVE DRUGS

39

Morphin (Chlohydrate)

Injection, ampoule of 10mg/ml

05 ampoules

40

Pethidin (Hydrochloride)

Injection, ampoule of 50mg/ml, ampoule of 2ml

05 ampoules

PSYCHOTROPIES, PRE-SUBSTANCES

41

Diazepam

Injection, ampoule of 10mg/2ml

Oral, tablet of 5mg

05 ampoules

10 tablets

42

Ergotamin (Tartrate)

Injection, ampoule of 0.5mg/ml

10 ampoules

43

Phenobacbital

Oral, tablet of 100mg

10 tablets

POISONS

44

Digoxin

Oral, tablet of 0.25mg

Injection, ampoule of 0.5mg/2ml

10 tablets

05 ampoules

45

Dopamin (Hydrochloride)

Injection, 40mg/ml ampoule of 5ml

05 ampoules

46

Epinephrin

Injection, ampoule of 1mg/1ml

05 ampoules

47

Haloperidol

Injection, ampoule of 5mg/1ml

05 ampoules

48

Mazipredon

Injection, ampoule of 30mg/1ml

05 ampoules

49

Methylprednisolon acetate

Injection, ampoule of 40-80mg

05 ampoules

50

Norepinephrine

Injection, ampoule of 1mg/1ml

05 ampoules

51

Papaverin

Injection, ampoule of 10mg/1ml

05 ampoules

52

Oxytoxin

Injection, ampoule of 5UI/1ml

10 ampoules

53

Pilocarpin (Nitrate)

Eye drops 2-4%

01 vial

54

Salbutamol (Sulfate)

Injection, ampoule of 0.5mg/2ml-5mg/5ml

05 ampoules

55

Tiemonium (Iodide)

Injection, ampoule of 0.5mg/2ml-5mg/5ml

05 ampoules

TRANSFUSION FLUIDS

56

Glucose

Infusion 5% bottle of 250ml-500ml

Infusion 30% bottle of 250ml-500ml

01 bottle

01 bottle

57

Sodium chloride

Infusion 0.9% bottle of 500ml

01 bottle

58

Ringger lartat

Infusion , bottle of 250-500ml

01 bottle

OTHERS

59

Oxygen for pharmaceutical use

Respiratory channel, liquefied gas cylinder

01 cylinder

Stipulations on the use of emergency drug list:

1. The addictive drugs are only used for general consultation clinics with confinement beds, specialized surgery consultation clinics and maternity homes. The infusion is carried out only at general consultation clinics with confinement beds and maternity homes.

2. The consultation clinics and maternity homes shall base themselves on this list of emergency drugs to make their emergency drug volumes suitable to their permitted professional operations.

3. Basing itself on the scope of professional practice of each form of medical establishment already approved and on the prescription of this drug list, the Health Ministry (the Pharmaceutical Management Department of Vietnam) shall approve the addictive drugs, psychotropics and poisons for foreign-invested establishments.-